J&J Says Covid-19 Vaccine Batch Didn't Meet Quality Standards -- Update

By Peter Loftus and Thomas M. Burton 

Johnson & Johnson said one batch of its new Covid-19 vaccine didn't meet quality standards at a contract manufacturer, and the doses weren't distributed.

J&J said Wednesday the batch never advanced to the filling and finish stages of its manufacturing process, and that the quality lapse wouldn't affect its ability to supply the U.S. with 100 million doses by the end of May.

J&J didn't disclose the nature of the quality lapse or how many doses were affected, but said it arose from quality checks during the start-up phase of manufacturing. The company said it shared information about the issue with the U.S. Food and Drug Administration.

The FDA is investigating, according to a person familiar with the matter.

The New York Times reported Wednesday that the J&J doses were ruined due to an accidental mix-up of ingredients at Emergent BioSolutions Inc., the contract manufacturer working with J&J. The Times reported that about 15 million doses were ruined.

Emergent declined to comment.

J&J's vaccine was the third to be authorized for use against Covid-19, after shots from Pfizer Inc. and its partner BioNTech SE and from Moderna Inc. Health authorities especially welcomed the addition of the J&J vaccine because it requires just one dose and is easier to store.

Supplies in the U.S. were expected to increase as J&J's manufacturing network ramped up production, accelerating a mass vaccination campaign that has been gaining steam.

J&J said it is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to oversee all manufacturing of the J&J vaccine there.

Emergent, a contract manufacturer based in Gaithersburg, Md., has been making the main ingredient for J&J's vaccine at an Emergent plant in Baltimore.

At the same plant, Emergent also makes the main ingredient for AstraZeneca PLC's Covid-19 vaccine, which hasn't yet been authorized for use in the U.S.

J&J's own plant in the Netherlands has been making the main ingredient for the initial U.S. supply of its vaccine -- including the nearly four million doses that were distributed immediately after it was authorized in late February.

J&J said it was able to meet a target of delivering a total of 20 million vaccine doses by the end of March. The company said it expects to deliver an additional 24 million doses in April, and plans to have delivered a total of 100 million by the end of May.

Write to Peter Loftus at [e-mail] and Thomas M. Burton at [e-mail]

(END) Dow Jones Newswires

March 31, 2021 19:27 ET (23:27 GMT)

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